Accriva Diagnostics, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0500-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.

Product Classification:

Class III

Date Initiated: October 21, 2025

Date Posted: November 19, 2025

Recall Number: Z-0500-2026

Event ID: 97863

Reason for Recall:

Due to an device without a premarket clearance being incorrectly package and distributed.

Status: Ongoing

Product Quantity: 125 boxes (3,125 tests)

Code Information:

Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

Distribution Pattern:

Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.

Voluntary or Mandated:

Voluntary: Firm initiated